Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
1.0
1269
Valid for 1269 days
Expiry: November 28, 2029
Basic Information
- Number
- ITH 1986726 1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- November 29, 2024
- Expiry Date
- November 28, 2029
- Revision
- 1.0
- Manufacturer
- Empatica S.r.L.
Certificate Lifecycle
Today
November 29, 2024
November 28, 2029
Conditions
English
The device is intended for the remote monitoring of physiological parameters and for the retrospective review of the collected physiological parameters.
Italian
Il dispositivo è destinato al monitoraggio a distanza di parametri fisiologici e alla revisione retrospettiva dei parametri fisiologici raccolti.
Scopes
2 scopes covering 1 risk classes
Quality Procedure Scope
Device Group
Class IIa
Dispositivi non impiantabili attivi per il monitoraggio dei parametri fisiologici vitali / Active non-implantable devices for monitoring of vital physiological parameters
Quality Procedure Scope
Device Group
Class IIa
Software / Software
Basic UDI-DIs
This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.